Functional Connectivity In Relation To Proprioception and Sensorimotor Recovery in Stroke Patients (Feasibility Study)

Stroke Clinical Trial

Official title:

Functional Connectivity In Relation To Proprioception and Sensorimotor Recovery in Stroke Patients (Feasibility Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02445768
• Other study ID #: PMR-2015-23168
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: February 28, 2023

Study information

• Verified date: March 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose now is to:

1. identify brain connections related to proprioception to have a better understanding of differences between people with stroke and healthy persons

2. evaluate how these brain connections will change in people with stroke when they are engaged in 6-week cognitive multisensory rehabilitation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Inclusion criteria for healthy subjects are:

• medically stable;

• 18 - 99 years of age;

• able to hear the instructions given during the study

Inclusion criteria for stroke patients are:

• at least 6 months post-stroke;

• medically stable;

• 18 - 99 years of age;

• subcortical or cortical infarct confirmed with MRI;

• Mini-mental State Exam > 24/30 (Folstein et al., 1975);

• able to hear the instructions given during the study;

• able to comprehend the instructions given during the study;

• able to commit time to participate in a 6-12-weeks rehabilitation program

Exclusion Criteria:

• having ever experienced a stroke or another brain injury or illness related to the brain that has lasting effects or effects experienced at the moment of recruitment;

• severe sensory impairments such that different movements of the finger, hand or wrist are not reliably felt;

• contractures in tested arm that hinder persons from keeping the outstretched arm in a relaxed position;

• interfering comorbidities (e.g. fracture, cancer, peripheral neuropathy);

• exhibit contra-indications to enter the magnetic field of the 3T (pacemakers, metal parts in the body etc);

• pregnant or nursing mother;

• adults lacking capacity to consent

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Cognitive multisensory rehabilitation

Locations

Country	Name	City	State
United States	University of Minnesota Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

References & Publications (1)

Van de Winckel A, De Patre D, Rigoni M, Fiecas M, Hendrickson TJ, Larson M, Jagadeesan BD, Mueller BA, Elvendahl W, Streib C, Ikramuddin F, Lim KO. Exploratory study of how Cognitive Multisensory Rehabilitation restores parietal operculum connectivity and improves upper limb movements in chronic stroke. Sci Rep. 2020 Nov 20;10(1):20278. doi: 10.1038/s41598-020-77272-y. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preliminary study to measure the brain mechanisms of cognitive multisensory rehabilitation	The robots will be used for research in healthy adults and stroke patients in the proposed studies below and are designed to mimick the exercises given during cognitive multisensory rehabilitation. The robots have been tested and cleared by the 3T safety committee at the CMRR, U of M. The first objective is a feasibility study to investigate the brain mechanisms of cognitive multisensory rehabilitation, through use of the robot in the 3T scanner at the U of M in healthy participants with stroke. Changes in brain function will be measured in individuals with stroke who will receive 8 weeks of therapy.	8 weeks

External Links

•   Related Info